MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-608
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This (b)(4) is related to (b)(4) which reports about the first pain which occurred after the first surgery on unknown date.This pc reports about the second pain which occurred on (b)(6) 2021 in the regular health follow-up for the knee.It was reported that on (b)(6) 2021, the patient underwent the total knee arthroplasty (tka) surgery for knee osteoarthritis with the knee femoral component, tibial tray, knee tibial insert in question.The surgery was completed successfully without any surgical delay.Two months after surgery, on unknown the patient felt pain and received the first treatment.After that on (b)(6) 2021, the patient visited the hospital for regular health follow-up for the knee, the patient felt pain while sitting on a hospital chair.When the surgeon examined the knee, it was confirmed that blood had accumulated, and the patient was treated to remove the second blood.The treatment was completed successfully.Doi: unknown.Dor: (b)(6) 2021, unknown side.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (impact code).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 6 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12554386
• Report Number: 1818910-2021-21560
• Device Sequence Number: 4080347
• Product Code: JWH
• UDI-Device Identifier: 10603295050094
• UDI-Public: 10603295050094
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1516-40-608
• Device Catalogue Number: 151640608
• Device Lot Number: HP8696
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 10/12/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/11/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE PS FB INSRT SZ 6 8MM; ATTUNE PS FEM LT SZ 6 CEM; CEMENT MFG AND PRODUCT NAME UNKNOWN; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE PS FB INSRT SZ 6 8MM; ATTUNE PS FEM LT SZ 6 CEM
• Outcome Attributed to Adverse Event: Required Intervention